MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Model Number	IPN915459
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The report states "there was a lack of light from the blade during the intubation.The light was flickering, there was a false contact.The consequence was a difficult intubation of the patient because the doctor did not see what he was doing.The handle was changed, which did not solve the problem".Additional information received states that the current condition of the patient is deceased, "patient was in state of brain death.Then, went to organs donor procedure".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
Qn# (b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states "there was a lack of light from the blade during the intubation.The light was flickering, there was a false contact.The consequence was a difficult intubation of the patient because the doctor did not see what he was doing.The handle was changed, which did not solve the problem".Additional information received states that the current condition of the patient is deceased, "patient was in state of brain death.Then, went to organs donor procedure".
Additional Manufacturer Narrative
(b)(4).Additional information received 22-may-2023 states the device was not contributory to the death of the patient.The customer reports that the patient desaturation level was 95%.It was also reported that the patient was not brain dead when the procedure began.The device was returned and sent to the manufacturing site for investigation.The manufacturing site reports: "the complaint of light flickering during the use of rusch greenlite mac 3 product is not a confirmed complaint.The customer returned one 004551003 rusch greenlite disp mtl mac 3 blade for investigation.The blade was returned to the site without its original pouch.The visual examination did not reveal any obvious defects or anomalies, as the device appear typical.The device history record for lot code 2106331 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to the release specification.The devices were tested for 100% functional testing prior to shipment to the customer.Based on the visual inspection, dimensional inspection and functional testing performed on the returned blade, it was observed that this complaint cannot be confirmed as there is no problem found on the complaint device during functional testing and based on the dimensional inspection results, it was noted that the critical dimension 0.50+0.10 mm (emboss height) meets the manufacturing and design/drawing release specification.The actual result for emboss height was noted to be 0.573 mm.The blade was found fully functional, and the blade was illuminating without any light flickering." other remarks: n/a.Corrected data: n/a.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 3
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16961863
• Report Number: 8030121-2023-00014
• Device Sequence Number: 5580062
• Product Code: CCW
• UDI-Device Identifier: 14026704711397
• UDI-Public: 14026704711397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2026
• Device Model Number: IPN915459
• Device Catalogue Number: 004551003
• Device Lot Number: 2106331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown